This invention relates generally to clinical trial compliance and, more particularly, to methods and systems for enhancing clinical trial compliance during a clinical trial.
Clinical trials are research studies designed to answer specific questions about new medical therapies or new ways of using known therapies. Generally, clinical trials are used to determine whether new drugs or treatments are safe and effective. Usually, individuals volunteer to become subjects who participate in clinical trials. At least some subjects may have health care insurance that is generally responsible for paying their medical service costs. However, should a patient become a clinical trial subject, certain medical services associated with the trial are reimbursed by a sponsor. For example, in a pharmaceutical clinical trial a pharmaceutical sponsor may agree to pay for drugs administered during a trial.
Full payment for clinical trial medical services may be collected from a subject's insurance or from the sponsor, but not both. Some known medical system software applications may send invoices to both the subject's insurance company and the sponsor—for the same medical service. Should fees ultimately be collected from both sources for the same service, the hospital or physician conducting the trial is considered non-compliant and may be subject to financial penalties levied by government agencies.
Consequently, hospitals and physicians involved with a clinical trial may have to make excessive write-offs to ensure billing compliance. Additionally, due to their software applications, they may be unaware that a patient is also a clinical trial subject, may encounter delays and errors in billing and collections for clinical trial activity, and may not consider scheduling subjects according to pre-defined protocols.